Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)

Title: Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Dental Research Training Program

Announcement Type:
This is a reissue of PAR-00-116, which was published in the NIH Guide June 28, 2000.

Update: The following updates relating to this announcement have been issued:

Program Announcement (PA) Number: PAR-05-101

Catalog of Federal Domestic Assistance Number(s)
93.121

Key Dates
Release Date: May 5, 2005
Letters of Intent Receipt Date(s): August 10 , 2005 , 2006, 2007
Application Submission Dates(s): September 10, 2005 , 2006, 2007
Peer Review Date(s): February 2006, 2007, 2008
Council Review Date(s) : May 2006, 2007, 2008
Earliest Anticipated Start Date: June 1, 2006, 2007, 2008
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: January 3, 2008

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

 Section I. Funding Opportunity Description
   1. Research Objectives

 Section II. Award Information
   1. Mechanism(s) of Support
   2. Funds Available

 Section III. Eligibility Information
   1. Eligible Applicants
     A. Eligible Institutions
     B. Eligible Individuals
   2. Cost Sharing
   3. Other - Special Eligibility Criteria

 Section IV. Application and Submission and Instructions
   1. Address to Request Application Information
   2. Content and Form of Application Submission
   3. Submission Dates and Times
     A. Receipt, Review and Anticipated Start Dates
       1. Letter of Intent
     B. Sending an Application to the NIH
     C. Application Processing
   4. Intergovernmental Review
   5. Funding Restrictions
   6. Other Submission Requirements

 Section V. Application Review Information
   1. Criteria
   2. Review and Selection Process
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Sharing Research Data
     D. Sharing Research Resources
   3. Anticipated Announcement and Award Dates

 Section VI. Award Administration Information
   1. Award Notices
   2. Administrative and National Policy Requirements
   3. Reporting

 Section VII. Agency Contact(s)
   1. Scientific/Research Contact(s)
   2. Peer Review Contact(s)
   3. Financial/ Grants Management Contact(s)

 Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement
Section I. Funding Opportunity Description

1. Research Objectives

Purpose of this PA

Background The National Research Service Award (NRSA) program has been used by the NIH as the primary means of supporting graduate and postdoctoral research training since enactment of the NRSA Legislation in 1974. This program uses a combination of institutional training grants and individual fellowships to ensure a continuing supply of well-trained scientists prepared to conduct cutting-edge health-related research. More information about NRSA programs is available at http://grants.nih.gov/training/nrsa.htm. Information on the career outcomes of predoctoral NRSA recipients is available at http://grants.nih.gov/training/career_progress/index.htm. The institutional research training grants described in this announcement provide support to training programs at institutions of higher education. Institutional NRSA training grants are designed to allow the director of the program to select the trainees and to develop a curriculum of study and research experiences necessary to provide high quality research training. The grant offsets the cost of stipends and tuition support for the appointed trainees. The following types of training can be supported by this grant: Predoctoral Training, Postdoctoral Training and Short-Term Research Training for Health-Professional Students. Program Objectives The National Institute of Dental and Craniofacial Research (NIDCR) invites new and competing continuation applications proposing Institutional Research Training programs. The Institute issues this program announcement in recognition of the need to develop a cadre of highly skilled, interactive scientists who can successfully address the expanding opportunities in dental, oral and craniofacial research. The award described in this announcement is designed to provide training opportunities in dental, oral and craniofacial research by supporting integrated but flexible institutional programs. The awards are comprehensive training grants to fund pre-doctoral, post-doctoral and short-term trainees. In addition, these awards can include a Dental Scientist Training Program (DSTP) to support trainees to obtain both the DDS/DMD and PhD degrees in an integrated program. The goals of this program are to: For the remainder of this PA, "Program" refers to the constellation of "programs" established at individual institutions. Proposed programs in response to this PA should endeavor to strengthen partnerships between schools of dentistry with schools in academic health centers and to foster training of researchers for the detection, diagnosis, prevention, management, and treatment of oral, dental, and craniofacial diseases and conditions.

Research Training Objectives

Background and Description

An expanding science base requires new research approaches that integrate various disciplines and levels of expertise in order to effectively address the increasing level of complexity in the interplay between genetic, environmental and socioeconomic factors in human disease. These factors are of special importance to address research needs in health promotion, disease prevention, diagnosis and treatment. Scientists must become familiar with the knowledge base and the methods of a wider variety of disciplines than is presently the case and investigators must develop a different and more diverse set of competencies, including the ability to interact in cross-disciplinary research teams. Training programs should provide the opportunity to develop these skills and to create environments which prompt life-long learning, successful research career transitions and pathways and strong collaborative and partnering skills.

Comprehensive programs will have the flexibility to provide short-term and long-term training opportunities and a continuum of personal development that spans the research career stages of the trainees. Training activities can be in basic biomedical or clinical sciences, in behavioral or social sciences, in population-oriented or health services research, or in any other disciplines relevant to dental, craniofacial and oral health. The comprehensive program should integrate research training for individuals throughout the continuum of educational and career levels; e.g., a clinical doctoral degree (i.e., through short-term research training programs); those pursuing a combined DDS/PhD degree (i.e., through a DSTP); those pursuing a PhD degree; or those pursuing postdoctoral training (i.e., through long-term training programs). In addition, the comprehensive programs may provide retraining opportunities for junior and mid-career faculty who wish to initiate new research activities, gain new research skills in topics relevant to the NIDCR areas of emphasis, or update existing skills and knowledge. Grantees are strongly encouraged to develop ways for trainees who are at different levels of experience and are funded by various mechanisms of training (e.g., the F or T types of NRSAs) or career development (e.g., the K series of NIH research career awards) to collaborate and work together at some point during the NRSA training experience.

It is not required that applicants propose a training program incorporating all possible components of comprehensive training. Institutional strengths should determine the scope and breadth of the training offered by each program. However, all applications must include a program for long-term training.

Specific Objectives

The objectives of this Program are to: (1) stimulate and accelerate collaborative, multi- and inter-disciplinary research training and education applicable to oral and craniofacial diseases, conditions, and disorders; (2) provide research training across the continuum of pre- and post-doctoral experience; and (3) establish an integrated, multidisciplinary and diverse workforce that will meet the current and future oral health research needs of the nation.

Priority will be given to programs that propose plans to train dentist scientists either as DSTPs, dentists training to the PhD or dentists training in a postdoctoral research experience.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH Ruth L. Kirschstein National Research Service (T32) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

Although NRSAs are not usually made for training leading to a health professional degree, this program is specifically designed to support training in an established, combined DDS/PhD program.

2. Funds Available

Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application if your organization meets the following criteria:

An eligible institution (e.g., university) may submit only a single application per application cycle in response to this PA. Multiple applications from different divisions, faculties, centers, schools, etc. at the same university will be returned without further consideration by the NIH.

Applicant institutions should be part of a health science center or of a regional consortium that has a strong research program in the proposed areas of training. In addition, they must have the requisite staff and facilities to carry out the proposed program. Further, they must be able to provide cross-disciplinary training opportunities through local collaborations with other professional or graduate schools.

1.B. Eligible Training Program Directors

Any individual with the skills, knowledge, and resources necessary to organize and implement a high quality research training program is invited to work with his/her institution as the director of the research training program in order to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The research training program director at the institution will be responsible for the selection and appointment of trainees to the NRSA research training grant and for the overall direction, management, and administration of the program.

2. Cost Sharing

Cost sharing is not required. The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

An eligible institution (e.g., university) may submit only a single application in response to this PA. Multiple applications from different divisions, faculties, centers, schools, etc. at the same university will be returned without further consideration by the NIH.

Eligible Trainees. Trainees appointed to the training program must have the opportunity to carry out supervised research with the primary objective of developing or extending their research skills and knowledge in preparation for a career in dental, oral and craniofacial research.

Eligible trainees must be educated minimally to the baccalaureate level and demonstrate a commitment towards research related to oral and craniofacial health.

At the time of appointment, trainees must: (1) be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-155) or some other verification of legal admission as a permanent resident. Individuals in the process of applying for such status or on temporary or student visas are not eligible; (2) be able to commit full-time effort, normally defined as 40 hours per week, in the program and its related research activities, consonant with NRSA guidelines (described further in PERIOD OF SUPPORT); (3) have a mentor with extensive research experience; (4) not be or have been a Principal Investigator on an R01 or R21 award or on a subproject of a Program Project (P01), Center (P50, P60, U54), or other equivalent research grant awards. Trainees may have had support on a NRSA grant (F or T), mentored career development (K-series) grant, or NIH small grant (R03).

Predoctoral Trainees. Predoctoral research training is for individuals who have a baccalaureate degree and are enrolled in a doctoral program leading to either a Ph.D., a comparable research doctoral degree, or a combined clinical degree and Ph.D, such as D.D.S./Ph.D.

For dual-degree predoctoral DSTP training, trainees must be enrolled in a formal, combined program that leads to the award of a D.D.S./D.M.D. and a Ph.D., or an equivalent degree, in one of the priority NIDCR research fields. Trainees must enter the program no later than their third year of professional school, although preference will be given to earlier appointment. Individuals already enrolled in a joint D.D.S./Ph.D. program are eligible for consideration as trainees. Dental students who wish to interrupt their studies to engage in full-time research training before completing their professional degrees are also eligible. Individuals who obtained a Ph.D. prior to entering dental school and desire to pursue another research doctorate while in dental school are not eligible for the DSTP. All trainees must have received a baccalaureate degree by the beginning date of their appointment.

Postdoctoral Trainees. Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., Pharm.D., N.D. (Doctor of Naturopathy), D.S.W., and Psy.D. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of training is acceptable.

Long-term positions (i.e., greater than three months) on NRSA institutional grants may not be used for study leading to the D.D.S., M.D., or other clinical, health-professional degrees, except when those studies are part of a formal combined research degree program, such as the D.D.S./Ph.D. Similarly, trainees may not accept NRSA support for studies that are part of residency training leading to clinical certification in a dental specialty or subspecialty. It is permissible, however, for clinicians to engage in NRSA supported full-time, postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board.

Short-Term Health-Professional Trainees. Short-term research training positions can support individuals for a time period not greater than three months in a grant year. Positions must involve full-time research training (i.e., at least 40 hours per week) and may be used for health professional students, clinical faculty who wish to gain research experience or learn research methodologies and mid-career scientists who want to update their knowledge of new research techniques and findings. To be eligible for short-term predoctoral research training positions, health professional students must be enrolled and in good standing, and should have completed at least one quarter in a program leading to a clinical doctorate prior to participating in the program. However, individuals with a strong research interest and an outstanding science background who have been accepted by a professional school but have not yet enrolled may be allowed to participate in short-term research training during the summer prior to starting school. Highly motivated health professional students and clinical faculty wishing to pursue a research career can be supported for additional three-month appointments beyond the initial training period.

All trainees are required to pursue their research training on a full-time basis, defined as at least 40 hours per week commitment to the program.

Trainees are also encouraged to apply to the NIH Loan Repayment Program (http://www.lrp.nih.gov/) if eligible.

Section IV. Application Submission Instructions

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms. Applicants should use the T32 guidelines and the PHS 398 application. Specific instructions for Institutional NRSA Applications begin on page 55 of the PHS 398 Instructions http://grants.nih.gov/grants/funding/phs398/phs398.pdf.

Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See Section VI.2 Administrative and National Policy Requirements for additional information.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Special Program Requirements, Allowable Costs and related information

A. Trainee Appointments

All trainees are required to pursue their research training full time, defined as 40 hours per week.

Trainee appointments are normally made in 12-month increments. No trainee may be appointed for less than 9 months during the initial period of appointment, except with the prior approval of the NIH awarding unit or when trainees are appointed to approved, short-term research training positions.

No individual trainee may receive more than 5 years of aggregate NRSA support at the predoctoral level or 3 years of support at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards.

Any exception to the maximum period of support requires a waiver from the NIH awarding office based on review of a justification from the individual and sponsoring institution. The fellow must make the request in writing to the NIH awarding office. The fellow's sponsor and an Authorized Organizational Official (AOO) must endorse the request. The request must specify the amount of additional support for which approval is sought. Individuals seeking additional support beyond the third year of postdoctoral support are strongly advised to consult with the NIDCR project officer before submitting a waiver request.

Some generally recognized categories under which NIH may grant exceptions include the following:

Requests for additional time that do not arise from either of the above-described circumstances will be considered only if they are accompanied by an exceptionally strong justification.

Service Payback Provisions

As specified in the NIH Revitalization Act of 1993, NRSA recipients incur a service payback obligation only during their first 12 months of postdoctoral support. Additionally, the Act specifies that the second and subsequent years of postdoctoral NRSA training will serve to pay back a postdoctoral service payback obligation. Accordingly, the following guidelines apply:

B. Budget and Related Issues

Applicants may request awards up to $700,000 in direct costs per year.

Allowable Costs:

1. Stipend: The NIH will provide stipend for each trainee position according to NRSA guidelines. A stipend is provided as a subsistence allowance to help trainees defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the awardee institution. Stipends must be paid to all trainees at the levels approved by the Secretary of the Department of Health and Human Services. Stipend levels are adjusted periodically and current stipend levels are available on the NIH website at: http://grants.nih.gov/training/nrsa.htm. The total stipend must be based on a 12-month appointment. The institution may supplement the NIH stipend up to a level that is consistent with the institution's scale from non-Federal sources only. It is expected that total stipends must be consistent with the level of effort, with the established stipend structure at the institution, and with stipends actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.

Funds characterized as compensation may be paid to trainees only when there is an employer-employee relationship, the payments are for services rendered, and the situation otherwise meets the conditions of the compensation of students as detailed in “ Cost Considerations—Allowability of Costs/Activities—Selected Items of Cost—Salaries and Wages—Compensation of Students.” In addition, compensation must be in accordance with organizational policies consistently applied to both federally and non-federally supported activities and must be supported by acceptable accounting records that reflect the employer-employee relationship. Under these conditions, the funds provided as compensation (salary, fringe benefits, and/or tuition remission) for services rendered, such as teaching or laboratory assistance, are not considered stipend supplementation; they are allowable charges to Federal grants, including PHS research grants. However, it is expected that compensation from research grants will be for limited part-time employment apart from the normal full-time training activities.

Compensation may not be paid from a research grant that supports the same research that is part of the trainee's planned training experience as approved in the Kirschstein-NRSA institutional research training grant application. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee's approved Kirschstein-NRSA training program. Training PDs must approve all instances of employment on research grants to verify that the circumstances will not detract from or prolong the approved training program.

An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation.

Taxation. The interpretation and implementation of the tax laws is the domain of the Internal Revenue Service (IRS) and the courts. The NIDCR takes no position on the status of a particular taxpayer, and it does not have the authority to dispense tax advice. Individuals should consult their local IRS office about the applicability of the law to their situation and for information on their tax obligations. See NRSA policy guidelines for further information http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm - _Toc54600187.

2. Tuition, Fees, and Health Insurance: The NIDCR will offset the combined cost of tuition, fees, and health insurance (either self-only or family as appropriate) at the current rates as published at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm. Costs associated with tuition and fees are allowable only if they are required for specific courses in support of the research training experience supported by the training grant. A full description of the tuition policy is contained within the NRSA Policy Guidelines on the NIH website at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm - _Toc54600204.

3. Training Related Expenses: Institutional costs of $2,200 a year per predoctoral trainee and $3,850 a year per postdoctoral trainee may be requested to defray the costs of other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and travel expenses for the training faculty. NRSA Training related expenses may be adjusted periodically in future fiscal years. Expenses for short-term trainees are prorated on the annual costs. Applicants may request compensation for up to 10% of a program director's direct salary and fringe benefits. This compensation is based on the total effort spent performing activities specifically related to implementing and conducting the proposed training program. No other institutional faculty or professional employees can be reimbursed through this award. Under exceptional circumstances, which can include providing accommodations for a trainee with disabilities, it is possible to request training-related expenses above the standard rate.

4. Trainee Travel Costs: Trainee travel to scientific meetings that the institution determines to be necessary for the individual's research training is an allowable trainee expense at $800 per trainee per year.

5. Facilities and Administrative Costs: A facilities and administrative allowance (indirect cost allowance) based on 8 percent of total allowable direct costs (this excludes amounts for tuition, fees, health insurance, and equipment) may be requested. See NRSA Policy Guidelines on the NIH Website at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm - _Toc54600204.

6. The number of trainees proposed in the application must be justified by available mentorship and by the recruitment and training track record of the applicant institution. The number of trainees by category recommended by study section is considered the ceiling, and may be further decreased by NIDCR Program Staff based upon availability of funds, track record for filling positions as assessed by annual progress reports and statements of appointment, and needs of the overall Program.

7. Carryover of Unobligated Balances: The carryover of funds from one budget period to the next requires prior written approval by NIDCR.

3. Submission Dates and Times
See Section IV.3.C for details.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): August 10 , 2005 , 2006, 2007
Application Submission Dates(s): September 10, 2005 , 2006, 2007
Peer Review Date(s): February 2006, 2007, 2008
Council Review Date(s) : May 2006, 2007, 2008
Earliest Anticipated Start Date: June 1, 2006, 2007, 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

H. George Hausch, PhD
Acting Director, Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
FAX: (301) 480-8303
Email: George.Hausch@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

H. George Hausch, PhD
Acting Director, Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
FAX: (301) 480-8303
Email: George.Hausch@nih.gov

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

6. Other Submission Requirements

A. Special Programmatic Requirements

1. Training in the Responsible Conduct of Research: Every NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research (see http://grants.nih.gov/grants/guide/notice-files/not92-236.html). Applications must describe a program to provide formal and informal instruction on scientific integrity and ethical principles in research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review.

Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review.

2. Program Director: The Program Director must possess the scientific background and leadership and administrative capabilities required to coordinate and supervise the proposed multidisciplinary research training program. For example, the Program Director may be a senior faculty member, Associate Dean for Research, Director of a research center or institute, or research training Director.

3. Research Capability and Infrastructure: The institution must demonstrate that it has a sufficiently funded research base, the infrastructure to support research and the facilities and resources to support research relevant to oral and craniofacial diseases and conditions.

4. Institutional Commitment: Applicant institutions should show commitment to the program's goals, and provide assurances that the institution intends the program to be an integral part of its research and research-training endeavor. Institutional commitment in support of the proposal must be evidenced by letters from high-ranking institutional officials (e.g., Provost, President and/or Vice-President) that describe how the proposed program will be an integral component of the institution's broader vision with respect to research, and provide a commitment of 100 percent protected time for the trainees, equivalent to 40 hours per week. The application must describe plans to provide support for trainees beyond the five-year project period in the event that funding from NIDCR is no longer available.

Applications that propose DSTP research training positions must provide evidence that the applicant institution is able to provide programs tailored to meet the unique research and clinical development needs of each DSTP trainee, and ensure that the individuals complete the clinical and research programs with requisite competencies in both. Applications should outline the timeline and schedule for the dual-degree program, and should provide evidence of the institution's commitment and ability to provide opportunities for an integrated training program for dual-degree students, including (A) didactic and experiential research components; (B) coordination among clinical, basic, behavioral and other science, dental/medical departments and the graduate school in the design and conduct of research programs; (C) availability of interdisciplinary research training; (D) availability of required and optional courses or seminars; (E) the process by which the trainee's guided research activities will be selected; (F) procedures for monitoring trainee's progress and post-dental school activities; (G) the unique and innovative aspects of the program; and (H) the plans to provide support for trainees in the event that continued funding from the NIDCR is not available.

5. Evaluation and Tracking Component: The application must describe a comprehensive evaluation and tracking component that will review the effectiveness of all aspects of the program (including curriculum, mentors, Advisory Committee members and activities, Program Directors), and a system for tracking trainees for a five-year period following program completion to determine program outcomes. Outcomes measures may be defined differently according to the level of training received. Examples of such outcomes may include relevant positions obtained, current activities related to research, publication record, and the success rate of applying for and obtaining Federal and non-Federal research grant support. Data for tracking should include annual application, enrollment, and appointment information (including degrees, disciplines, and specialties) and course of study (e.g., short-term, long-term, degree-seeking, etc.). While by necessity the Program Director will be involved in providing the information for evaluation and tracking, it is desirable that the application describes a prospective evaluation plan for process and outcome measures. The evaluation report will be due at the time of termination of the award as part of the final report. If five years have not passed at the time the evaluation report is due, an interim evaluation report will be substituted.

6. Recruitment Plan: Applicants must submit a recruitment plan that includes a scheme for recruiting trainees from both outside and inside their institution(s). Demonstrated ability to recruit trainees will be a key factor in determining the number of training slots awarded.

Applications proposing a DSTP program should include a discussion of methods for identifying and recruiting DDS/PhD dual degree trainees, including efforts to develop collaborations with undergraduate educational educations.

7. Minority Recruitment and Retention Plan: The NIH remains committed to increasing the participation of individuals from underrepresented minority groups in biomedical and behavioral research. As first announced in 1989, all competing applications for institutional NRSA research training grants must include a specific plan to recruit and retain underrepresented minorities in the training program. In addition, all competing continuation applications must include a report on the recruitment and retention of underrepresented minorities during the previous award period. If an application is received without a plan or without a report on the previous award period, the application will be considered incomplete and will be returned to the applicant without review. Additional information on this requirement was published in the NIH Guide for Grants and Contracts, Volume 22, Number 25, July 16, 1993 (see http://grants.nih.gov/grants/guide/notice-files/not93-188.html).

Competing continuation and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies. The report should provide information on the racial/ethnic distribution of:

For those trainees who were enrolled in the academic program, the report should include information about the duration of research training and whether those trainees finished their training in good standing.

B. Special Administrative Requirements

1. Leave: In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the grantee institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Trainees may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Trainees may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director.

A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken. Individuals requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence. At the beginning of a leave of absence, the trainee must submit a Termination Notice (PHS Form 416-7) and upon return from the leave of absence, the trainee must be formally reappointed to the grant by submitting an updated Statement of Appointment (PHS Form 2271). Trainees within the first twelve months of postdoctoral support must also submit a Payback Agreement (PHS Form 6031) upon return from a leave of absence.

2. Off-site training: Training in another institution may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such training does not exceed three months. For longer periods, prior written approval of NIDCR staff is required. To obtain prior approval, the Program Director must submit a letter to NIDCR Program Staff describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the off-site training is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the award will continue during such training, provided that it relates to the training program.

3. Change of Institution: The Program may not be transferred from one institution to another. Trainees seeking to change institutions must terminate their current appointment following guidelines for termination as described above, and apply directly to the desired program.

4. Change of Program Director: If change of a Program Director is necessary, support of the award is not automatic, but may be continued with NIDCR prior approval, provided:

5. Changes of Program: Awards are made to a specific institution for a specific program under the guidance of a particular Program Director. Changes in any of these parameters require prior approval by NIDCR Program Staff. A rationale must be provided for any proposed changes in the aims of the original peer-reviewed program. Programmatic changes will be evaluated by NIDCR Program Staff to ensure that the program remains within the scope of the original peer-reviewed application.

Plan for Sharing Research Data
Not applicable to NRSA Training Grants.

Sharing Research Resources
Not applicable to NRSA Training Grants.

Section V. Application Review Information

1. Criteria

The role of peer review is to assess the extent to which the applicant is likely to develop and run a successful training program. Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDCR in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The responsibility for award decisions resides solely with authorized program staff of the NIDCR. The following criteria will be used in making award decisions:

The goals of NIH-supported research training and career development programs are to help ensure that a diverse pool of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research training plan will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

Overall Program Aims: Does the application address the need for comprehensive training of oral and craniofacial investigators? If the aims of the application are achieved, how will they impact upon the shortage of well-trained oral health investigators? What will be the effect of the proposed training program on studies, concepts, or methods that drive oral health research?

Approach: Is the conceptual framework and design of the training program adequately developed and integrated, and appropriate to the goal of training dental, oral and craniofacial research scientists? Does the applicant acknowledge past barriers and potential problem areas and consider alternative tactics? Does the applicant present plans and evidence that the program will train both dentist scientists – either as DSTPs, dentists training to the PhD, or dentists training in a postdoctoral research experience – and non-dentist scientists? Is the training plan organized to promote quality cross-disciplinary and inter-professional research training of all trainees? Will the project encourage the interaction among predoctoral, post-doctoral and short-term trainees during didactic and/or research activities?

Innovation: Is the program original and innovative? For example, does the program challenge existing training or career approaches, or address a critical barrier to progress in the training of oral health researchers? Does the program develop or employ novel concepts, approaches, methodologies, tools, or technologies for research education that will lead to the recruitment and training of oral health researchers? Does the program provide strong evidence that the addition of the T32 Program will provide clinical research training that would not otherwise be possible?

Program Director: Does the Program Director possess the scientific background and administrative experience appropriate to coordinate and supervise a comprehensive and integrative oral health research training program? Does the Program Director have adequate time to commit to program administration? Will the Program Director have sufficient authority and credibility in the Institution to work across institutional boundaries (if applicable)?

Institutional Commitment: Is there evidence that the institution is committed to the goals of the program? Does the application include letters from high-ranking institutional officials (e.g., Provost, President and/or Vice-President) that describe how the proposed program will be an integral component of the institution's broader vision with respect to research? Does the institution provide a commitment of 100 percent protected time for the trainees, equivalent to 40 hours per week?

Training Environment: Does the environment in which the training program will be conducted contribute to the probability of success? Is there evidence of partnering with schools within the academic health center and/or other universities? Is there evidence of inter- and multi-disciplinary and inter-professional research training opportunities through well-integrated core and supplemental curricula? Is there evidence of ongoing basic and clinical research, and availability of appropriate and relevant research support, equipment, facilities, and research resources?

Candidate Pool and Recruitment Plans: Does the application demonstrate well-defined recruitment procedures, potential sources, and number of high-quality candidates, trainee selection criteria, and retention strategies? Are these processes adequate to achieve a high-quality pool of trainees? Does the program seek to recruit trainees from outside the institution? Are there adequate plans to recruit women and members of underrepresented racial/ethnic minorities? Is the number of trainees proposed in the application justified by available mentorship, recruitment methodology and training track record of the applicant institution?

Past research training record: Is there evidence of success of former trainees in seeking further career development and in establishing productive scientific careers? Evidence of further career development can include receipt of fellowships, career awards, additional training appointments, and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors, a record of publications, receipt of patents, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the training received.

Mentors: Does the application demonstrate a representative sample of mentors sufficient to support the proposed number of trainees? Do the mentors have adequate time commitment for the duration of the program? Do the mentors have sufficient expertise and experience as evidenced by the mentors' accomplishments in basic, translational and/or clinical research; current and pending research grant awards; and mentoring experience of predoctoral and postdoctoral fellows?

Advisory Committee: Does the application describe the composition and role of an advisory committee in development of the program, assignment of mentors and projects, development of recruitment strategies, monitoring trainee progress and evaluation of progress?

Evaluation/Tracking: Is the proposed evaluation plan sufficiently detailed? Are the plans to evaluate the performance of the Program as a whole (e.g., quality of the cores, adequacy of the performance of mentors, adequacy of faculty participation), and to make changes that improve performance and outcomes adequate? Are there adequate plans to track career outcomes of trainees, including subsequent training, positions held, papers published, grants and awards submitted/obtained, and other relevant information?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Short-Term Research Training Positions: Applications that request short-term research training positions will be further assessed using the following criteria:

DSTP Component: For applications that propose DSTP research training positions:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed training-related research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the training-related research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the training-related project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Minority Recruitment And Retention Plan: The success of efforts to recruit and retain minority trainees is a factor in the assessment of the quality of the trainee pool and thus will be included within the priority score. In addition, peer reviewers will separately evaluate the minority recruitment plan after the overall score has been determined. The review panel's evaluation will be included in an administrative note in the summary statement. If the plan or the record of minority recruitment and retention is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. NIDCR program staff, with guidance from the National Advisory Dental Research Council, will determine whether amended plans and reports submitted after the initial review are acceptable.

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. NIDCR program staff will judge the acceptability of the revised plan.

2.C. Sharing Research Data
Not applicable to NRSA Training Grants.

2.D. Sharing Research Resources
Not applicable to NRSA Training Grants.

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Grant Award will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

For more information and detailed requirements, please refer to the NIH Grants Policy, particularly the section regarding the Individual Fellowships of the Ruth L. Kirschstein National Research Service Awards. http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600187.

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

3. Reporting

The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant. This Form must be completed at the beginning of the initial appointment and annually thereafter. Additionally, a completed Payback Agreement (PHS Form 6031) must be submitted for each postdoctoral trainee in their first twelve months of support. Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS Form 416-7). Failure to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. All of these forms are available on the NIH website at http://grants.nih.gov/grants/forms.htm#training.

Progress Reports: An Annual Progress Report is required. This report should provide information about changes in the program, a summary report by the Advisory Committee, and a description of the research and career progress of each trainee. These Annual Progress Reports will be closely monitored by NIH staff to ensure that the grant is achieving the goals of the overall Program.

Progress reports are submitted using the Form PHS 2590, which can be obtained at the following website address: http://grants.nih.gov/grants/funding/2590/2590.htm. In addition to the required information, the following information should be included:

Final Reports: A final progress report and Financial Status Report are required within 90 days after the end of the grant project period or upon relinquishment of an award.

Evaluation: In carrying out its stewardship of human resource-related programs, the NIDCR may request information essential to an assessment of the effectiveness of this Program. Accordingly, recipients are hereby notified that they may be contacted during and after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the Program.

Financial Reporting: An annual FSR is required for all Kirschstein-NRSA institutional research training grant awards no later than 90 days after the close of each budget period. This report will document the financial status of the grant according to the official accounting records of the grantee organization. Trainee stipends and tuition are obligated for the full 12-month appointment from the budget period in which the appointment is initiated. Portions of stipends and tuition that extend beyond the budget period are carried over as unliquidated obligations. However, if the report covers the final budget period of the project period, it must have no unliquidated obligations and must indicate the exact balance of unobligated funds (see “ Administrative Requirements—Monitoring—Reporting—Financial Reports” and “ Administrative Requirements—Closeout—Final Reports”).

Publications and Sharing of Research Results: NIH supports the practical application and sharing of outcomes of funded research. Therefore, PDs and trainees should make the results and accomplishments of their Kirschstein-NRSA institutional training grant activities available to the research community and to the public at large. The grantee organization should assist trainees in these activities, including the potential commercialization of inventions. No restrictions should be placed on the publication of results.

Trainees are encouraged to submit reports of their findings for publication to the journals of their choice. Responsibility for direction of the project should not be ascribed to NIH. However, NIH support must be acknowledged by a footnote in language similar to the following: “This investigation was supported by the National Institutes of Health under Ruth L. Kirschstein National Research Service Award (number) from the NIDCR.” In addition, Federal funding must be acknowledged as provided in “ Public Policy Requirements and Objectives—Availability of Information—Acknowledgment of Federal Funding.”

Copyright: Except as otherwise provided in the conditions of the award, when a publication or similar copyrightable material is developed from work supported by NIH, the author is free to arrange for copyright without approval of the NIH awarding office. Any such copyrighted materials shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Federal government to reproduce them, translate them, publish them, and use and dispose of them, and to authorize others to do so for Federal government purposes.

Inventions and Patents: All Kirschstein-NRSA institutional research training grants and other funding agreements awarded primarily for educational purposes are not subject to invention reporting requirements nor does NIH have any rights to inventions under those grants and agreements (as specified in 45 CFR 74.24(h) and in 37 CFR 401.1(b)).

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contact:

Kevin S. Hardwick, DDS, MPH
Extramural Training Officer
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AS13
Bethesda, MD 20892
Telephone: (301) 594-2765
FAX: (301) 402-7033
Email: kevin.hardwick@nih.gov

2. Peer Review Contact:

H. George Hausch, PhD
Acting Director, Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
45 Center Drive, Room 4AN-44F
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
FAX: (301) 480-8303
Email: George.Hausch@nih.gov

3. Financial or Grants Management Contact:

Dede Rutberg, MBA
Grants Management Specialist
Grants Management Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN44J
Bethesda, Maryland 20892-6402
Telephone: (301) 594-4798
FAX:  (301) 480-3562
Email: dr258t@nih.gov or rutbergd@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

Kirschstein-NRSA institutional research training grants involving human subjects must comply with the requirements for their protection (see “ Public Policy Requirements and Objectives—Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services—Human Subjects”). If the applicant organization has an approved FWA or other applicable assurance on file with OHRP but, at the time of application, plans for the involvement of human subjects are indefinite, the assurance number should be provided on the face page of the application. If an award is made, human subjects may not be involved until a certification of IRB approval or designation of exemption has been submitted.

In many instances, trainees supported by Kirschstein-NRSA institutional research training grants will be participating in research supported by research project grants for which the IRB review is already completed or an exemption is already designated. This review or exemption designation is sufficient, provided the research would not be substantially modified by the participation of a trainee. The appropriate grants must be identified along with their IRB review dates or exemption designation.

For additional information on human subjects requirements, refer to the PHS 398 or contact OHRP (see Part III for contact information).

Monitoring Plan and Data and Safety Monitoring Board:
Research involving clinical trials must include provisions to ensure the safety of participants and the validity and integrity of the data. A monitoring plan establishes the overall framework for data and safety monitoring. It should describe the entity that will be responsible for monitoring and how adverse events will be reported to IRBs, NIH, and FDA. The frequency of monitoring will depend on potential risks, complexity, and the nature of the trial.

NIH specifically requires the establishment of DSMBs for multi-site clinical trials involving interventions that entail potential risks to the subject and, generally, for Phase III clinical trials. Although Phase I and Phase II clinical trials also may use DSMBs, smaller clinical trials may not require this type of oversight, and alternative monitoring plans may be appropriate.

PDs and trainees also should refer to the NIH Policy for Data and Safety Monitoring at http://grants.nih.gov/grants/guide/notice-files/not98-084.html, “ Public Policy Requirements and Objectives - Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services—Data and Safety Monitoring” in Subpart A, and the instructions in the PHS 398 application.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is NIH policy that women and members of minority groups and their subpopulations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research (see “ Public Policy Requirements and Objectives—Requirements for Inclusiveness in Research Design”). This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October 2001, is available on the NIH website at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.

Inclusion of Children as Participants in Clinical Research:
NIH policy requires that children (individuals under the age of 21) be included in all human subjects research conducted or supported by NIH, unless there are scientific and ethical reasons not to include them (see “ Public Policy Requirements and Objectives—Requirements for Inclusiveness in Research Design”).

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm.

Required Education on The Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov) It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

Use of Animals in Research:
Kirschstein-NRSA institutional research training grants involving use of vertebrate animals must comply with the requirements for their protection specified in “ Public Policy Requirements and Objectives—Requirements Affecting the Right and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services—Animal Welfare.”

If the applicant organization has an approved Assurance of Compliance on file with OLAW but, at the time of application, its plans for the involvement of vertebrate animals are so indefinite that IACUC review and approval are not feasible, on the face page of the application, the organization should check “Yes,” include the animal welfare Assurance of Compliance number, and indicate “Indefinite.” If an award is made, vertebrate animals may not be involved until verification of the IACUC approval date has been submitted to the NIH awarding office.

In many instances, trainees supported by institutional research training grants will be participating in research supported by research project grants for which the IACUC review already is completed. This review is sufficient, provided the research would not be substantially modified by the participation of a trainee. The appropriate grants must be identified along with their IACUC review dates.

If the applicant organization does not have an approved Assurance of Compliance on file with OLAW or for additional information on vertebrate animals, refer to the PHS 398 or contact OLAW (see Part III).

Recombinant DNA Molecules and Human Gene Transfer Research:
Institutions receiving Kirschstein-NRSA institutional research training grants involving use of recombinant DNA molecules must comply with the requirements of the NIH Guidelines for Research Involving Recombinant DNA Molecules (see “ Public Policy Requirements and Objectives—Ethical and Safe Conduct in Science and Organizational Operations—NIH Guidelines for Research Involving Recombinant DNA Molecules and Human Gene Transfer Research”). The NIH Guidelines, available from NIH's OBA (see Part III), should be consulted for complete requirements for the conduct of projects involving recombinant DNA techniques. The NIH Guidelines are available at http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html.

Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance No. 93.121. Awards are made under authorization of section 487 of the Public Health Service Act as amended (42 USC 288) and administered under Title 42 of the Code of Federal Regulations, Part 66.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


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NIH Funding Opportunities and Notices


H H S Department of Health
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  N I H National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892